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CERAMENT

CERAMENT is the platform technology on which BONESUPPORT’s business is based.

CERAMENT is a synthetic bone graft substitute that consists of a powder component: 40% hydroxyapatite (HA), 60% calcium sulfate (CaS), and a liquid component (iohexol in CERAMENT®|BONE VOID FILLER, CERAMENT®|SPINE SUPPORT and CERAMENT® V, and saline in CERAMENT®|G, which are mixed to form an injectable paste . It is used to fill gaps or voids in bone to promote bone healing.

The  type and ratio of HA and CaS in CERAMENT gives it unique material properties including the ability to remodel into host bone within 6-12 months.

  • These attractive properties have resulted in more than 25,000 patients having  been treated with CERAMENT and

  • Interest in CERAMENT has resulted in over 120 publications and abstracts, confirming safety and efficacy

CERAMENT’s key properties include:

REMODELS INTO HOST BONE WITHIN 6-12 MONTHS

With CERAMENT, simultaneous de novo bone formation is seen throughout the material and it is fully remodeled into host bone within 6-12 months. Rapid bone remodeling reduces the risk of fracture, non-union and (re)infection.

 

REFERENCES

CERAMENT® BONE VOID FILLER Bone healing technical monograph - PR 0278-01 EN

Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 10(5), 675-684, 2013

Abramo et al. Osteotomy of dorsally displaced malunited fractures of the distal radius: No loss of radiographic correction during healing with a minimally invasive fixation technique and an injectable bone substitute. Acta Orthop 79:262-268, 2008

Bark et al. Case Report: Arthroscopic-Assisted Treatment of a Reversed Hill-Sachs Lesion: Description of a New Technique Using CERAMENT®. Case Reports in Orthopedics, Volume 2015, Article ID 789203, 5 pages. http://dx.doi.org/10.1155/2015/789203

Kaczmarczyk et al. Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study. BMC Musculoskeletal Disorders (2015) 16:369. DOI 10.1186/s12891-015-0828-3

DO 0037. Data on file, BONESUPPORT AB, Sweden

INJECTABLE

CERAMENT can be injected through a 16G needle, making it ideal for minimally invasive procedures. Injectability is enhanced by the shape of the hydroxyapatite (HA) particles, enhancing flow and enabling injection to be performed without the need for high pressure.

 

REFERENCES

CERAMENT® BONE VOID FILLER Bone healing technical monograph - PR 0278-01

EN Nilsson, M. Injectable calcium sulphate and calcium phosphate bone substitutes. Lund University. 2003. ISBN: 91-628-5603-0

Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 10(5), 675-684, 2013

Ishikawa K. Effects of spherical tetracalcium phosphate on injectability and basic properties of apatitic cement, pp 369-372, 2003

Dr Desai. Case study - Bicondylar osteoporotic tibial plateau fracture management utilising CERAMENT®. PR 0262-02 EN

FLOWABLE

Flowability ensures excellent spread into and around a bone defect. This is particularly important for complex defects, where the extent of bone loss may not be apparent at first and certain areas may be difficult to access.

 

REFERENCES

CERAMENT® BONE VOID FILLER Bone healing technical monograph - PR 0278-01

EN Nilsson, M. Injectable calcium sulphate and calcium phosphate bone substitutes. Lund University. 2003. ISBN: 91-628-5603-0

Dr. Papadia. White paper - Displaced intra-articular calcaneal fractures treated with open reduction internal fixation (ORIF) combined with an injectable and bone remodeling bone substitute - PR 0293-01 EN

Benign bone tumors – Surgical Technique – PR 0405-02 EU/US

Calcaneous fracture – Surgical Technique – PR 0404-02 – EU/US

Acetabular revision – Surgical Technique – PR0408-02 en EU/US

RADIOPAQUE

This allows for the precise application of CERAMENT as it is easy to visualize under fluoroscopy.

Hydroxyapatite (HA) and calcium sulfate (CaS) are naturally radiopaque, but in CERAMENT®|BONE VOID FILLER, CERAMENT®|SPINE SUPPORT and CERAMENT® V radiopacity is enhanced by a liquid component called C-TRU®, consisting of the radiopaque agent iohexol.

 

REFERENCES

CERAMENT® BONE VOID FILLER Bone healing technical monograph - PR 0278-01 EN

Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 10(5), 675-684, 2013

Nilsson, M. Injectable calcium sulphate and calcium phosphate bone substitutes. Lund University. 2003. ISBN: 91-628-5603-0

CERAMENT® BONE VOID FILLER Instructions for Use – IFU 0004-08

CERAMENT® G Instructions for Use – IFU 0014-02

CERAMENT® SPINE SUPPORT Instructions for Use - IFU 0003-10

CERAMENT® V Instructions for use - IFU0016-02

Internal reports DO073, DO083. , DO0188, DO0225 BONESUPPORT AB, Sweden

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

Lindberg et al. Antibiotic elution and bone remodelling with a novel bone substitute impregnated with gentamicin. Presentation given at EBJIS 2012.

CERAMENT® Antibiotic eluting bone substitutes brochure – PR 0421-01 en EU

ISOTHERMIC

CERAMENT does not create heat during setting, so there is no risk of thermal injury to tissues.

 

REFERENCES

Internal reports S090/2007(CBVF & CSS), S081/2011(CG) and S016/2013 (CV), BONESUPPORT AB, Sweden

NOT TEMPERATURE SENSITIVE

Setting time and handling properties are consistent and reliable irrespective of the temperature of the operating room (OR).

CERAMENT is also conveniently stored at room temperature.

 

REFERENCES

Internal report S057/2010, BONESUPPORT AB, Sweden

CERAMENT® BONE VOID FILLER Instructions for Use – IFU 0004-08

CERAMENT® G Instructions for Use – IFU 0014-02

CERAMENT® SPINE SUPPORT Instructions for Use - IFU 0003-10

CERAMENT® V Instructions for use - IFU0016-02

CERAMENT'S SELF-CONTAINED MIXING DEVICE MAKES IT EASY TO MIX AND USE

The pre-filled, sterile, mixing and injection device ensures hassle-free preparation and delivery. The mixing device is simple to use and helps to achieve a homogenous paste, enhances rheology (flow characteristics) and reduces waiting time prior to application. It also reduces the risk of contamination, and there are no toxic or unpleasant fumes.

 

REFERENCES

CERAMENT® BONE VOID FILLER Instructions for Use – IFU 0004-08

CERAMENT® G Instructions for Use – IFU 0014-02

CERAMENT® SPINE SUPPORT Instructions for Use - IFU 0003-10

CERAMENT® V Instructions for use - IFU0016-02

REFERENCES

Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 10(5), 675-684, 2013

CERAMENT™ BONE VOID FILLER  Bone healing technical monograph - PR 0278-01 EN

CERAMENT™ BONE VOID FILLER Instructions for Use – IFU 0004-08

CERAMENT™ G Instructions for Use – IFU 0014-02

CERAMENT™ V Instructions for use - IFU0016-02

CERAMENT™ SPINE SUPPORT Instructions for Use - IFU 0003-10